Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC…
Reason LABELING: LABEL MIX-UP.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason LABELING: LABEL MIX-UP.
Reason Discoloration
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Reason Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
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